6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD) - Full Text View

Purpose

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD-0332334	Phase III

MedlinePlus related topics:

Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Official Title:	A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder

Further study details as provided by Pfizer:

Primary Outcome Measures:

Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
The nature, incidence, duration, and severity of adverse events. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory [ Time Frame: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist ] [ Designated as safety issue: Yes ]
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound [ Time Frame: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A). [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU) ] [ Designated as safety issue: No ]
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire. [ Time Frame: Twice at Wk 13 and Wk 26/EOT ] [ Designated as safety issue: No ]
Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD. [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT ] [ Designated as safety issue: No ]
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy . [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Not Specified: Experimental Not Specified	Drug: PD-0332334 Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women age > 65 years.
A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

Exclusion Criteria:

Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738738

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361036
First Received:	August 12, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00738738
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Generalized Anxiety Disorder Elderly

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00738738